title: A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy.
abstract: BACKGROUND
  Orally administered, food-specific immunotherapy appears effective in desensitizing and potentially permanently tolerizing allergic individuals.
  
  
  OBJECTIVE
  We sought to determine whether milk oral immunotherapy (OIT) is safe and efficacious in desensitizing children with cow's milk allergy.
  
  
  METHODS
  Twenty children were randomized to milk or placebo OIT (2:1 ratio). Dosing included 3 phases: the build-up day (initial dose, 0.4 mg of milk protein; final dose, 50 mg), daily doses with 8 weekly in-office dose increases to a maximum of 500 mg, and continued daily maintenance doses for 3 to 4 months. Double-blind, placebo-controlled food challenges; end-point titration skin prick tests; and milk protein serologic studies were performed before and after OIT.
  
  
  RESULTS
  Nineteen patients, 6 to 17 years of age, completed treatment: 12 in the active group and 7 in the placebo group. One dropped out because of persistent eczema during dose escalation. Baseline median milk IgE levels in the active (n = 13) versus placebo (n = 7) groups were 34.8 kUa/L (range, 4.86-314 kUa/L) versus 14.6 kUa/L (range, 0.93-133.4 kUa/L). The median milk threshold dose in both groups was 40 mg at the baseline challenge. After OIT, the median cumulative dose inducing a reaction in the active treatment group was 5140 mg (range 2540-8140 mg), whereas all patients in the placebo group reacted at 40 mg (P = .0003). Among 2437 active OIT doses versus 1193 placebo doses, there were 1107 (45.4%) versus 134 (11.2%) total reactions, with local symptoms being most common. Milk-specific IgE levels did not change significantly in either group. Milk IgG levels increased significantly in the active treatment group, with a predominant milk IgG4 level increase.
  
  
  CONCLUSIONS
  Milk OIT appears to be efficacious in the treatment of cow's milk allergy. The side-effect profile appears acceptable but requires further study.
authors.affiliation: Department of Pediatrics, Division of Allergy and Immunology, the Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
authors.forename: Justin M
authors.initials: JM
authors.lastname: Skripak
authors.forename: Scott D
authors.initials: SD
authors.lastname: Nash
authors.forename: Hannah
authors.initials: H
authors.lastname: Rowley
authors.forename: Nga H
authors.initials: NH
authors.lastname: Brereton
authors.forename: Susan
authors.initials: S
authors.lastname: Oh
authors.forename: Robert G
authors.initials: RG
authors.lastname: Hamilton
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Matsui
authors.forename: A Wesley
authors.initials: AW
authors.lastname: Burks
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wood
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D002648:Child; D003888:Desensitization, Immunologic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D008297:Male; D016269:Milk Hypersensitivity / Q000097:blood / Q000276:immunology / Q000628:therapy*; D008894:Milk Proteins / Q000008:administration & dosage* / Q000276:immunology; D012074:Remission Induction
chemical_list: D008894:Milk Proteins; D007073:Immunoglobulin E